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Une étude sur le védolizumab chez des adultes atteints de colite ulcéreuse ou de maladie de Crohn en milieu communautaire (PANORAMA)

27 octobre 2026 mis à jour par: Takeda

Une étude de phase 4 évaluant la colite ulcéreuse ou la maladie de Crohn modérée à sévèrement active et l'utilisation du vedolizumab par voie sous-cutanée en milieu communautaire

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).

Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.

During the study, participants will visit their study clinic several times.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

200

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35243
        • Recrutement
        • Gastro Health
        • Contact:
        • Chercheur principal:
          • Robert Shaffer
      • Mobile, Alabama, États-Unis, 36608
        • Recrutement
        • East View Medical Research
        • Chercheur principal:
          • Jonathan Siegel
        • Contact:
    • Arizona
      • Chandler, Arizona, États-Unis, 85225
        • Recrutement
        • AZ Gastro Care
        • Contact:
        • Chercheur principal:
          • Shahbaz Ali Qureshi
      • Gilbert, Arizona, États-Unis, 85297
        • Recrutement
        • Spectrum Research Institute LLC
        • Chercheur principal:
          • Donna DeSantis
        • Contact:
      • Sun City, Arizona, États-Unis, 85351
    • Arkansas
      • Little Rock, Arkansas, États-Unis, 72205
        • Retiré
        • UAMS Health Gastroenterology Clinic
    • California
      • Escondido, California, États-Unis, 92025
        • Recrutement
        • Gastroenterology and Liver Institute
        • Chercheur principal:
          • Naveen Gara
        • Contact:
      • Murrieta, California, États-Unis, 92562
        • Retiré
        • Inland Empire Gastroenterology
      • Murrieta, California, États-Unis, 92563
        • Recrutement
        • United Clinical Research Institute
        • Chercheur principal:
          • John Hong
        • Contact:
      • Newport Beach, California, États-Unis, 92663
        • Retiré
        • Digestive Health Institute
      • Orange, California, États-Unis, 92868
        • Retiré
        • Knowledge Research Center
      • San Diego, California, États-Unis, 92123
        • Retiré
        • Medical Associates Research Group, Inc.
    • Colorado
      • Colorado Springs, Colorado, États-Unis, 80907
        • Recrutement
        • Peak Gastroenterology Associates
        • Chercheur principal:
          • Bhaktasharan Patel
        • Contact:
      • Littleton, Colorado, États-Unis, 80120
        • Recrutement
        • Rocky Mountain Endocopy Centers LLC
        • Chercheur principal:
          • Erik Springer
        • Contact:
    • Florida
      • Brooksville, Florida, États-Unis, 34613
        • Recrutement
        • Access Research Institute
        • Contact:
        • Chercheur principal:
          • Salman Muddassir
      • Clearwater, Florida, États-Unis, 33762
        • Recrutement
        • Gastro Florida
        • Contact:
        • Chercheur principal:
          • Michael Weiss
      • Hialeah, Florida, États-Unis, 33016
        • Retiré
        • Doral Medical Research, LLC
      • Kissimmee, Florida, États-Unis, 34741
        • Recrutement
        • Digestive and Liver Center of Florida, P.A.
        • Chercheur principal:
          • Basher Atiquzzaman
        • Contact:
      • Miami, Florida, États-Unis, 33176
        • Recrutement
        • Gastro Health Research - Miami
        • Contact:
        • Chercheur principal:
          • Joanna Lopez
      • Orlando, Florida, États-Unis, 32803
        • Recrutement
        • Endoscopic Research, Inc.
        • Contact:
        • Chercheur principal:
          • Marlon Ilagan
      • Orlando, Florida, États-Unis, 32825
        • Retiré
        • Digestive and Liver Center of Florida
      • Orlando, Florida, États-Unis, 32806
        • Recrutement
        • Orlando Health-Orlando Regional Medical Center
        • Chercheur principal:
          • Udayakumar Navaneethan
        • Contact:
      • Pensacola, Florida, États-Unis, 32504
        • Recrutement
        • Gastro Health Research - Pensacola
        • Chercheur principal:
          • Frederic Newman
        • Contact:
      • Pinellas Park, Florida, États-Unis, 33781
        • Recrutement
        • West Central Gastroenterology d/b/a Gastro Florida
        • Chercheur principal:
          • Tejinder Glamour
        • Contact:
    • Georgia
      • Atlanta, Georgia, États-Unis, 30327
        • Recrutement
        • Digestive Healthcare of Georgia
        • Contact:
        • Chercheur principal:
          • Michael Galambos
      • Atlanta, Georgia, États-Unis, 30342
        • Recrutement
        • AGA GA Research LLC
        • Chercheur principal:
          • Justin Mendel
        • Contact:
      • Decatur, Georgia, États-Unis, 30033
        • Retiré
        • Atlanta Center for Gastroenterology, P.C.
    • Illinois
      • Downers Grove, Illinois, États-Unis, 60515
        • Recrutement
        • Yapp, Rockford M.D. (Private Practice)
        • Chercheur principal:
          • Rockford Yapp
        • Contact:
          • Site Contact
          • Numéro de téléphone: 859-999-4506
          • E-mail: rgjsy34@aol.com
      • Glenview, Illinois, États-Unis, 60026
        • Recrutement
        • GI Alliance - Glenview
        • Contact:
        • Chercheur principal:
          • Nina Merel
      • Lake Barrington, Illinois, États-Unis, 60010
        • Recrutement
        • Gastroenterology and Internal Medicine Specialists, SC
        • Chercheur principal:
          • Manish Bhuva
        • Contact:
      • Naperville, Illinois, États-Unis, 60540
        • Retiré
        • Suburban Gastroenterology
      • Oak Lawn, Illinois, États-Unis, 60453
        • Recrutement
        • GI Partners of Illinois - Southwest Gastroenterology
        • Chercheur principal:
          • Charles Berkelhammer
        • Contact:
      • Rockford, Illinois, États-Unis, 61107
        • Recrutement
        • Rockford Gastroenterology Associates, Ltd.
        • Chercheur principal:
          • Sunil Patel
        • Contact:
      • Springfield, Illinois, États-Unis, 62703
        • Recrutement
        • Springfield Clinic
        • Contact:
        • Chercheur principal:
          • Dmitry Shuster
    • Indiana
      • Westfield, Indiana, États-Unis, 46074
        • Recrutement
        • Riverview Health
        • Chercheur principal:
          • Sashidhar Sagi
        • Contact:
    • Kansas
      • Hutchinson, Kansas, États-Unis, 67502
        • Recrutement
        • Hutchinson Clinic
        • Contact:
        • Chercheur principal:
          • Michael Green
    • Kentucky
      • Crestview Hills, Kentucky, États-Unis, 41017
        • Recrutement
        • Tri-State Gastroenterology Associates
        • Chercheur principal:
          • Michael Jones
        • Contact:
    • Louisiana
      • Baton Rouge, Louisiana, États-Unis, 70809
        • Recrutement
        • Baton Rouge General Medical Center - Bluebonnet Campus
        • Chercheur principal:
          • Jonathon Chapman
        • Contact:
      • Lafayette, Louisiana, États-Unis, 70503
        • Recrutement
        • Combined Gastro LLC
        • Chercheur principal:
          • Jacque Noel
        • Contact:
      • Metairie, Louisiana, États-Unis, 70006
        • Recrutement
        • GI Alliance
        • Chercheur principal:
          • George Catinis
        • Contact:
    • Maine
      • Portland, Maine, États-Unis, 04101
        • Recrutement
        • Portland Gastroenterology Center
        • Contact:
        • Chercheur principal:
          • Noemi Baffy
    • Maryland
      • Chevy Chase, Maryland, États-Unis, 20815
      • Glen Burnie, Maryland, États-Unis, 21061
        • Recrutement
        • Woodholme Gastroenterology
        • Chercheur principal:
          • Kenolisa Onwueme
        • Contact:
    • Massachusetts
      • Framingham, Massachusetts, États-Unis, 01702
        • Recrutement
        • Gastro Health Research - Framingham
        • Contact:
        • Chercheur principal:
          • Steven Fine
      • New Bedford, Massachusetts, États-Unis, 02740
        • Recrutement
        • Lucida Clinical Trials LLC
        • Chercheur principal:
          • Jason Reich
        • Contact:
    • Michigan
      • Wyoming, Michigan, États-Unis, 49519
        • Recrutement
        • Gastroenterology Associates of Western Michigan, P.L.C.
        • Contact:
        • Chercheur principal:
          • Allan Coates
      • Ypsilanti, Michigan, États-Unis, 48197
        • Recrutement
        • Huron Gastro
        • Chercheur principal:
          • Najm Soofi
        • Contact:
    • Minnesota
      • Plymouth, Minnesota, États-Unis, 55446
        • Retiré
        • MNGI Digestive Health, P.A.
    • Mississippi
      • Southaven, Mississippi, États-Unis, 38671
        • Recrutement
        • Delta Gastroenterology and Endoscopy Center
        • Contact:
        • Chercheur principal:
          • Ulric Duncan
    • Missouri
      • Bridgeton, Missouri, États-Unis, 63044
        • Recrutement
        • SSM Health Medical Group
        • Chercheur principal:
          • Yezaz Ghouri
        • Contact:
      • Columbia, Missouri, États-Unis, 65201
        • Recrutement
        • GI Associates Research, LLC
        • Chercheur principal:
          • Michael Williams
        • Contact:
      • Kansas City, Missouri, États-Unis, 64111
        • Recrutement
        • Mid America Gastro Intestinal Consultants
        • Chercheur principal:
          • Hillary Bownik
        • Contact:
      • Weldon Spring, Missouri, États-Unis, 63304
        • Recrutement
        • St Charles Clinical Research
        • Chercheur principal:
          • Leonard Weinstock
        • Contact:
          • Site Contact
          • Numéro de téléphone: 314-567-3377
          • E-mail: lw@gidoctor.net
    • Nevada
      • Reno, Nevada, États-Unis, 89511
        • Retiré
        • Advanced Research Institute
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87107
        • Retiré
        • Presbyterian Health care services
    • New York
      • Carmel, New York, États-Unis, 10512
        • Recrutement
        • Westchester Putnam Gastroenterology PC
        • Contact:
        • Chercheur principal:
          • Rajiv Perinbasekar
      • Cedarhurst, New York, États-Unis, 11516
        • Recrutement
        • Five Towns Gastroenterology
        • Contact:
        • Chercheur principal:
          • Marc Fenster
      • Elmhurst, New York, États-Unis, 11373
        • Recrutement
        • IMIDeology
        • Chercheur principal:
          • Kevin Tin
        • Contact:
      • Fresh Meadows, New York, États-Unis, 11040
        • Recrutement
        • Intercity Gastroenterology
        • Chercheur principal:
          • Ghulamullah Shahzad
        • Contact:
      • Lake Success, New York, États-Unis, 11042
        • Retiré
        • NYU Langone Long Island Clinical Research Associates
      • New York, New York, États-Unis, 10075
        • Retiré
        • Lenox Hill Hospital
      • New York, New York, États-Unis, 10075
        • Recrutement
        • New York Gastroenterology Associates
        • Contact:
        • Chercheur principal:
          • Ana Tuyama
      • New York, New York, États-Unis, 10279
        • Retiré
        • Manhattan Clinical Research, LLC
      • Rochester, New York, États-Unis, 14620
        • Retiré
        • Gastroenterology Group of Rochester
      • Seaford, New York, États-Unis, 11783
        • Recrutement
        • ProHealth (Seaford) (Optum)
        • Contact:
        • Chercheur principal:
          • Corina Serer
      • Syracuse, New York, États-Unis, 13210
        • Retiré
        • Syracuse VA Medical Center
      • Utica, New York, États-Unis, 13502
        • Recrutement
        • Digestive Disease Medicine
        • Chercheur principal:
          • Harvey Allen
        • Contact:
      • West Nyack, New York, États-Unis, 10994
        • Recrutement
        • Crystal Run (Optum)
        • Contact:
        • Chercheur principal:
          • Tehseen Haider
    • North Carolina
      • Charlotte, North Carolina, États-Unis, 28207
        • Recrutement
        • Charlotte Gastroenterology and Hepatology, P.L.L.C
        • Contact:
        • Chercheur principal:
          • John Gardiner Roddey
      • Greenville, North Carolina, États-Unis, 27834
        • Recrutement
        • Carolina Digestive Diseases
        • Chercheur principal:
          • Phillip Goldstein
        • Contact:
      • Pinehurst, North Carolina, États-Unis, 28374
        • Retiré
        • Pinehurst Medical Clinic Inc
      • Statesville, North Carolina, États-Unis, 28625
      • Wilmington, North Carolina, États-Unis, 28403
        • Recrutement
        • Wilmington Gastroenterology Associates
        • Contact:
        • Chercheur principal:
          • William King
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45219
        • Recrutement
        • Gastro Health Research - Cincinnati
        • Contact:
        • Chercheur principal:
          • Matthew Atkinson
      • Dayton, Ohio, États-Unis, 45414
        • Recrutement
        • DSI Research Northridge LLC
        • Contact:
        • Chercheur principal:
          • Rajeev Kurapati
      • Liberty Township, Ohio, États-Unis, 45044
        • Recrutement
        • Gastro Health Research - Liberty Township
        • Contact:
        • Chercheur principal:
          • Stephen Martin
      • Mentor, Ohio, États-Unis, 44060
        • Recrutement
        • Great Lakes Gastroenterology Research, LLC
        • Contact:
        • Chercheur principal:
          • Keith Friedenberg
      • Springboro, Ohio, États-Unis, 45066
        • Recrutement
        • DSI Research LLC
        • Chercheur principal:
          • Anjali Morey
        • Contact:
      • Westlake, Ohio, États-Unis, 44145
        • Recrutement
        • NorthShore Gastroenterology Research, LLC
        • Chercheur principal:
          • Kimberly Harris
        • Contact:
    • Oregon
      • Portland, Oregon, États-Unis, 97220
        • Recrutement
        • The Oregon Clinic, P.C.
        • Chercheur principal:
          • Phillip Kiyasu
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02904
        • Recrutement
        • University Gastroenterology
        • Chercheur principal:
          • Lisa Mueller
        • Contact:
    • South Carolina
      • Summerville, South Carolina, États-Unis, 29486
        • Recrutement
        • Palmetto Primary Care Physician Division of Gastroenterology
        • Chercheur principal:
          • Brett Van Leer-Greenberg
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, États-Unis, 57105
        • Recrutement
        • Sanford Center for Digestive Health
        • Chercheur principal:
          • Ahmed Kurdi
        • Contact:
    • Tennessee
      • Kingsport, Tennessee, États-Unis, 37663
        • Recrutement
        • Tri-Cities Gastroenterology
        • Chercheur principal:
          • Stephen Fry
        • Contact:
    • Texas
      • El Paso, Texas, États-Unis, 79936
        • Recrutement
        • The Clinical Trials Network CTNX LLC
        • Contact:
        • Chercheur principal:
          • Ikenna Egbuna
      • Georgetown, Texas, États-Unis, 78628
        • Recrutement
        • Amel Med LLC
        • Chercheur principal:
          • Masi Khaja
        • Contact:
      • Houston, Texas, États-Unis, 77005
        • Recrutement
        • Kelsey Research Foundation
        • Contact:
        • Chercheur principal:
          • Sheela Chandra
      • Houston, Texas, États-Unis, 77090
        • Recrutement
        • Spring Clinical Research
        • Chercheur principal:
          • Sushma Gorrela
        • Contact:
      • Houston, Texas, États-Unis, 77079
        • Recrutement
        • MedCare Pharma LLC
        • Contact:
        • Chercheur principal:
          • Alan Glombicki
      • Houston, Texas, États-Unis, 77090
        • Retiré
        • Integrity Advanced Therapeutics
      • Katy, Texas, États-Unis, 77494
        • Recrutement
        • Gastro Health & Nutrition
        • Chercheur principal:
          • Dharmendra Verma
        • Contact:
      • Kingwood, Texas, États-Unis, 77339
        • Recrutement
        • One of a Kind Clinical Research Center LLC
        • Chercheur principal:
          • Sushovan Guha
        • Contact:
      • Lubbock, Texas, États-Unis, 79424
        • Recrutement
        • West Texas Research Institute
        • Contact:
        • Chercheur principal:
          • Sameer Islam
      • Tomball, Texas, États-Unis, 77375
        • Retiré
        • Texas Gastro Consultants
      • Waco, Texas, États-Unis, 76712
        • Recrutement
        • Digestive Research of Central Texas, LLC
        • Chercheur principal:
          • Hanumantha Ancha
        • Contact:
      • Webster, Texas, États-Unis, 77598
        • Recrutement
        • GI Alliance - Webster
        • Contact:
        • Chercheur principal:
          • Syed Jafri
    • Utah
      • Ogden, Utah, États-Unis, 84405
        • Retiré
        • Advanced Research Institute
    • Virginia
      • Roanoke, Virginia, États-Unis, 24014
        • Recrutement
        • Gastroenterology Consultants of Southwest Virginia.
        • Chercheur principal:
          • Nirish Shah
        • Contact:
      • Suffolk, Virginia, États-Unis, 23435
        • Retiré
        • Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research
      • Williamsburg, Virginia, États-Unis, 23188
        • Retiré
        • TMPG Clinical Research
    • Washington
      • Bellevue, Washington, États-Unis, 98405
        • Recrutement
        • GI Alliance
        • Chercheur principal:
          • Nicholas Procaccini
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria

To be eligible to participate in this study, participants must meet all the following criteria:

  1. In the investigator's opinion, the participant can understand and comply with protocol requirements.

  2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.

  3. The participant is 18 to 80 years of age at the time of signing the ICF.

  4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI).

  5. Participants must meet the contraception recommendations.

  6. The participant has a diagnosis of moderate to severely active UC or CD defined by the following:

    1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD >=6 (>=4 if isolated ileal disease) at screening OR
    2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy sub-score of 2 to 3 at screening.

  7. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.

  8. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy.

Exclusion Criteria

Participants who meet any of the following exclusion criteria will be excluded from participation in this study:

  1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181]) at any time prior to screening.

  2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.

  3. Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).

  4. In the investigator's opinion, the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has a medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients.

  5. Received any investigational biologic therapy <= 6 months prior to screening.

  6. The participant has received an advanced treatment for an approved indication other than CD or UC within 60 days prior to screening.

    a. Advanced therapies include tumor necrosis factor (TNF) inhibitors, 12/23 antagonists, janus kinase (JAK) inhibitors, and sphingosine-1-phosphate (S1P) receptor modulators.

  7. The participant has any evidence of an active infection during screening.

  8. Ileostomy, colostomy, severe or symptomatic stenosis of the intestine, or short bowel syndrome.

  9. A surgical procedure requiring general anesthesia within 30 days prior to screening or planned or possible major surgery during the study period.

  10. History of malignancy, except for adequately treated nonmetastatic basal cell skin cancer; adequately treated squamous cell skin cancer that has not recurred for at least 1 year before screening; and adequately treated cervical carcinoma in situ that has not recurred for at least 3 years before screening. Participants with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and therapy received; this must be discussed with the sponsor on a case-by-case basis before enrollment.

  11. Participants with any unstable or uncontrolled cardiovascular conditions, moderate to severe heart failure (New York Heart Association Class III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorders that, in the investigator's opinion, would confound the study results or compromise participant safety.

  12. Participants with active cerebral or meningeal disease, signs or symptoms or a history of progressive multifocal leukoencephalopathy (PML), or any other major neurological disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.

  13. Participant is not on a stable dose of corticosteroid.

  14. Has any of the following laboratory abnormalities during the screening period: (a) hemoglobin <8 grams per deciliter (g/dL); (b) white blood cell (WBC) count <3.0 × 10^9 per liter (L); (c) lymphocyte count <0.5 × 10^9/L; (d) platelet count <100 × 10^9/L or >1200 × 10^9/L; (e) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3.0 × the upper limit of normal (ULN); or (f) alkaline phosphatase (ALP) >1.5 × ULN. Historical laboratory data may be used for screening if available in the participant's electronic health record (EHR) within 6 weeks before screening.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: UC Participants: Vedolizumab

Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
Médicament: Vedolizumab IV

Vedolizumab IV infusion

Autres noms:
  • Entyvio
Médicament: Vedolizumab SC

Vedolizumab SC injection

Autres noms:
  • Entyvio
Expérimental: CD Participants: Vedolizumab

Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
Médicament: Vedolizumab IV

Vedolizumab IV infusion

Autres noms:
  • Entyvio
Médicament: Vedolizumab SC

Vedolizumab SC injection

Autres noms:
  • Entyvio

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
Délai: At Week 14

PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (<=) 2.8, 7-day average of abdominal pain (AP) score <= 1.0, and neither worse than baseline.
At Week 14
Percentage of UC Participants With PRO-2 Remission at Week 14
Délai: At Week 14

PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score <=1.
At Week 14

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
Délai: At Weeks 6 and 52

PRO-2 remission for CD participants is defined as 7-day average of very soft or liquid SF <= 2.8, 7-day average of AP score <= 1.0, and neither worse than baseline. PRO-2 remission for UC participants is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score <=1.
At Weeks 6 and 52
Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52
Délai: At Weeks 6, 14, and 52

CD clinical response is defined as greater than and equal to (>=) 100 points decrease from baseline in CDAI score. UC clinical response is defined as reduction in complete Mayo score of >=3 points and >=30 percent (%) from baseline with an accompanying decrease in rectal bleeding sub-score of >=1 point or absolute rectal bleeding sub-score of <=1 point or an absolute rectal bleeding sub-score of <=1 point, or a reduction in partial Mayo score of >=2 points and >=25% from baseline, if complete Mayo score was not performed at visit.
At Weeks 6, 14, and 52
Percentage of CD Participants With Endoscopic Response at Week 52
Délai: At Week 52

Endoscopic response is defined as a >=50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing.
At Week 52
Percentage of CD Participants Achieving Endoscopic Remission at Week 52
Délai: At Week 52

Endoscopic remission as per SES-CD is defined as a SES-CD score of 0 to 4, with no individual sub-score greater than 1. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing.
At Week 52
Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52
Délai: At Week 52

Improvement of endoscopic appearance of the mucosa is defined as Modified Mayo endoscopic sub-score (MMES) of 0 or 1.
At Week 52
Percentage of UC Participants With Endoscopic Remission at Week 52
Délai: At Week 52

Endoscopic remission is defined as a centrally read complete Mayo endoscopy sub-score of 0.
At Week 52
Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52
Délai: At Weeks 6, 14, and 52

Clinical Remission for CD is defined as a CDAI <150 point. Clinical remission for UC is defined as complete MS of <=2 points and no participant sub-score greater than (>) 1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, physician's global assessment [PGA]) score of <=2 and no individual sub-score >1.
At Weeks 6, 14, and 52
Percentage of CD and UC Participants With Clinical Remission at Week 52
Délai: At Week 52

Clinical remission for CD is defined as a CDAI <150 point. Clinical remission for UC is defined as complete MS of <=2 points and no participant sub-score >1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, PGA) score of <=2 and no individual sub-score >1. Percentage of CD and UC participants with clinical remission at Week 52, among those participants who achieved clinical remission at Week 6 and 14 will be reported.
At Week 52
Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, 26, and 52
Délai: Baseline, Weeks 6, 14, 26, and 52

Change from baseline in CRP levels of CD and UC participants at Weeks 6, 14, 26, and 52 will be reported.
Baseline, Weeks 6, 14, 26, and 52
Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52
Délai: Baseline, Weeks 6, 14, and 52

Change from baseline in fecal calprotectin concentrations of CD and UC participants at Weeks 6, 14, and 52 will be reported.
Baseline, Weeks 6, 14, and 52
Percentage of CD and UC Participants With Serious Infections
Délai: Up to end of study (up to 72 weeks)

Percentage of CD and UC participants with serious infections will be reported.
Up to end of study (up to 72 weeks)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Takeda

Les enquêteurs

  • Directeur d'études: Study Director, Takeda

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 mars 2025

Achèvement primaire (Estimé)

1 mai 2027

Achèvement de l'étude (Estimé)

1 juin 2028

Dates d'inscription aux études

Première soumission

30 août 2024

Première soumission répondant aux critères de contrôle qualité

30 août 2024

Première publication (Réel)

3 septembre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Vedolizumab-4063

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Critères d'accès au partage IPD

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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